Kornimate/medical-research-clean huggingface dataset:
this study will evaluate the persistence of hepatitis a antibodies, 8 years and 10 years later, in children who had received havrix at selected health centres of panama

Conditions: Hepatitis A Vaccine

Summary: the purpose of this study is to evaluate the persistence of hepatitis a antibodies, approximately 8 years and 10 years post vaccination with the complete series of havrix (2 doses) and the partial series completion (1 dose).

the study comprises of two independent cross-sectional surveys (year 8 and year 10). the first cross-sectional serosurvey will evaluate the long term persistence of immunity approximately 8 years post vaccine administration and the second cross-sectional study will evaluate long term persistence, approximately 10 years post vaccine administration.

Eligibility criteria:
inclusion criteria: * subjects whose parent(s)/ lar(s), in the opinion of the investigator, can and will comply with the requirements of the protocol. * written informed assent/consent obtained from the subject or subject's parent(s)/ lar(s) of the subject. * available hav vaccination records. * children who have received either 1 or two doses of havrix at selected health centres of panama. * children with ≥ 7 years and \< 10 years between last dose and persistence visit 1 (year 8) and children ≥ 10 years and \< 13 years between last dose and persistence visit 1' (year 10). exclusion criteria: * child in care. * subjects with history of vaccination with other hepatitis a vaccines other than havrix. * subjects with known past history of hepatitis a infection, both without vaccination and after they received the last dose of havrix (1 dose or the complete 2 dose schedule).

Keywords: havrix cross-sectional seroprevalence survey panama long-term persistence hepatitis
a crossover study to determine the effect on lung function of indacaterol in patients with moderate to severe chronic obstructive pulmonary disease (copd), using tiotropium as an active control

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure * co-operative out patients with a diagnosis of chronic obstructive pulmonary disease (copd) (moderate to severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2006) and: 1. smoking history of at least 10 pack years (current or previous smokers) 2. post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥30% of the predicted normal value. 3. post-bronchodilator fev1/forced vital capacity (fvc) \< 70% exclusion criteria: * patients who have been hospitalized for a copd exacerbation in the 6 weeks prior to visit 1 or during the run-in period * patients requiring long-term oxygen therapy for chronic hypoxemia * patients who have had a respiratory tract infection within 6 weeks prior to visit * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * any patient with active cancer or a history of cancer with less than 5 years disease free survival time * patients with a history of long qt syndrome or whose qtc interval (bazett's) measured at visit 1 or randomization is prolonged * patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period. * patients unable to successfully use a dry powder inhaler device, mdi or perform spirometry measurements other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic obstructive pulmonary disease, indacaterol, tiotropium, placebo controlled
covid-19 pregnancy related immunological, clinical and epidemiological factors and perinatal outcomes

Conditions: Covid19

Summary: this is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal covid-19 infection, followed up to 6 weeks postpartum.

this proposal aims to provide a multi-faceted approach to addressing perinatal covid-19 infection by (1) improving our understanding of sars-cov-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with covid-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, covid-19, and early neonatal outcomes. (4) evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the covid-19 vaccine

Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 in pregnancy or within 6 months post partum * planned delivery at thomas jefferson university hospital exclusion criteria: * declines routine covid testing on admission * in active labor/pain/otherwise unable to provide consent
warming up to sensors: does site warming improve continuous glucose monitor performance?

Conditions: Type 1 Diabetes

Summary: this study will investigate the effect of wearing a small warming patch, the insupatch, at the site of the continuous glucose monitor (cgm), also called a sensor. specifically, we will be looking to see if using the insupatch (ip) improves the accuracy of the continuous glucose monitor.

hypotheses: 1. warming of the skin and subcutaneous tissue with the insupatch device will improve the accuracy of a cgm as compared to a cgm used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard. 2. warming of the skin and subcutaneous tissue with the insupatch device will reduce the lag time of the cgm, as compared to a cgm used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard. 3. the combination of the insupatch device and a cgm will be well-tolerated and not cause skin irritation.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least 12 months. 2. age 8 years to less than 45 years old. 3. subject understands the study protocol and agree to comply with it. 4. subject is on insulin pump or injection-based basal-bolus therapy 5. subject comprehends written english. 6. for females, subject not intending to become pregnant during the study. 7. informed consent form signed by the subject 8. no history of altered skin integrity, poor wound healing, adhesive allergy, or previous infection from sensor wear. 9. hemoglobin a1c ≤10% exclusion criteria: 1. the presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol 2. the presence of any of the following diseases: a. current use of systemic corticosteroids (within the last week) b. other major illness that in the judgment of the investigator might interfere with the completion of the protocol i. adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment 3. inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian) 4. current or past use of a continuous glucose sensor is not an exclusion criterion. 5. active skin condition that would affect sensor placement 6. use of acetaminophen or vitamin c supplement within the last 7 days 7. subject is deemed by the investigator to be unwilling or unable to follow the protocol; 8. pregnancy a negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. subjects who become pregnant will be discontinued from the study. -

Keywords: type 1 diabetes continuous glucose sensor insupatch
turkish validity and reliability of the expanded rehabilitation complexity scale

Conditions: Stroke

Summary: the rcs is a tool that can assess the need for complex rehabilitation and objectively indicate that a patient may have difficulty functioning well at home or in the community if their medical needs are still high. among rehabilitation patients, there are still patients with complex needs, even though they have maximized rehabilitation potential. moreover, rcs can also be useful in highlighting cases of patients becoming seriously ill during the rehabilitation process due to an acute illness such as sepsis, which significantly limits treatment time. this information can be emphasized using rcs data when requesting extended or increased rehabilitation support.

the rehabilitation complexity scale (rcs) is similarly designed to provide a simple measure of the complexity of rehabilitation needs and/or interventions; this can be implemented in a timely manner and takes into account essential care, specialist nursing, therapy and medical interventions. clauses in the rcs state that care, nursing, therapy and medical input needs are the primary 'causes' of case complexity and (together with length of stay) will ultimately affect a particular individual. compliance in healthcare processes is a very current issue, with particular emphasis on the individualization of rehabilitation settings. compliance has been described by who as a complex issue with various dimensions and definitions, and these vary between countries. however, most definitions of appropriateness address a set of basic requirements: that care be effective (based on valid evidence); be efficient (cost-effective); and is consistent with the ethical principles and preferences of the individual, society or society concerned. it is thought that rcs will meet these needs.the research population will be 110 patients selected from the patients hospitalized in the palliative unit of istanbul physical therapy and rehabilitation hospital.the sample size was determined as 110. medcalc program was used in the analysis. linear regression analysis was performed. cronbach-alpha was calculated as 97%.stabil subacute stroke patients will be included in the study. barthel, fim, rcs-e tools will be used in the study.

Eligibility criteria:
inclusion criteria: clinical diagnoses of stroke - exclusion criteria: unstable cardiac and neurovascular disease -

Keywords: rehabilitation complexity scale; needs assessment
notion: in-home sampling of cytokines in immunotherapy patients

Conditions: Cancer; Metastatic Melanoma; Renal Cell Carcinoma; Non-small Cell Lung Cancer

Summary: this study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. the data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.

patients will be informed of the study and given a minimum of 24 hours to consider. once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.

Eligibility criteria:
inclusion criteria: * voluntary informed consent. * aged at least 18 years. * diagnosis of locally advanced or metastatic rcc, melanoma or nsclc * in the opinion of the investigator deemed suitable to receive first-line combination immunotherapy (rcc and mm) or combination immunotherapy and chemotherapy (nsclc). * willingness to comply with scheduled trial procedures. * capable of performing own dry blood sampling procedure, or a carer who is willing and able to perform them. exclusion criteria: * previous immunotherapy (including any cpi either as single agent on in combination, or high dose interleukin-2). * judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements. * patients receiving long term oral anticoagulation deemed by the clinician to be at risk from daily finger pricking.

Keywords: immunotherapy immune related adverse event cytokine release
iressa case control study in japan

Conditions: Non-small Cell Lung Cancer

Summary: the purposes of this study are: * to estimate the relative risk of ild in advanced/recurrence nsclc patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ild in advanced/recurrence nsclc patients undergoing treatment * to provide an estimate of the incidence of ild in a group of advanced/recurrence nsclc patients undergoing treatment


Eligibility criteria:
inclusion criteria: * advanced/recurrence nsclc patients who have had one or more chemotherapy regimens. * patients who are to be treated with gefitinib or chemotherapy * cohort: all advanced/recurrence nsclc patients participating in this post-marketing clinical study exclusion criteria: * patients judged by the investigator(s) to have ild (provisional cases) among those registered in the cohort or randomly selected patients without ild (controls) for each provisional case * case-control study: patients enrolled in the case-control study; all consenting patients with ild as cases and approximately 4 times as many consenting patients without ild as controls randomly selected from the cohort
study of the prevalence and associated factors with hypogonadism in hiv + men

Conditions: Hypogonadism; HIV

Summary: testosterone deficiency is classically associated with the development of metabolic syndrome, osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and alteration of the quality of patients life. chronicity of hiv infection leads to several disorders as fever, chronic stress, weight loss and cachexia which are the cause of hypogonadotropic hypogonadism. on the other hand, abnormal secretion of cytokines, secondary to the infection may alter the leydig cells causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. cases of testicular invasion by lymphoma or kaposi's syndromes have also been described. the advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients infected with hiv that is currently about 20%. this prevalence remains about 20%, regardless of the antiretroviral therapy and cd4-t cell count. no study to our knowledge has so far assessed exhaustively the clinical features, biological, therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum testosterone, shbg and serum free testosterone, among hiv infected patients in the european population.

assess the prevalence and clinical, biological, paraclinical and therapeutic factors associated with primary or secondary hypogonadism in hiv treated and virologically suppressed patients.

Eligibility criteria:
inclusion criteria: * men aged 18-50 years at the inclusion visit * under antiretroviral treatment for more than six months with undetectable viral load (last sample older than four months before the visit of run) * infection by hiv-1 positive (confirmation by a full western blot or by measurement of plasma hiv rna prior to the inclusion) * lack of co-infections hbv, hcv (last negative serology older than 6 months before the screening visit inclusion) * consent signed by the patient and the investigator the day of the inclusion and before any examination required by the test (article l1122-1-1 the code of public health) * patient affiliated or beneficiary of a social security system of the european community member countries (article l1121-11 of the code of public health). exclusion criteria: * infection by hiv-2 * all stages of cirrhosis * severe renal impairment (creatinine clearance below 30 ml / min) * opportunistic infection during treatment or opportunistic infection in history * neoplastic pathology being processed * taken in the previous 3 months of testosterone and other anabolic agents, antiandrogens, estrogens, glucocorticoids, analog gnrh, growth hormone or human insulin-like growth factor-1 (igf-1) * pituitary, adrenal or testicular pathologies , treated or not * presence or history of psychotic disorder and / or high suicide risk * refusal to participate * no one under safeguard justice * patients participating in another research evaluating other treatments and including an exclusion period ongoing at the inclusion

Keywords: hiv hypogonadism metabolic syndrom reservoirs osteodensitometry erectil dysfonction depression
a safety and efficacy study of lansoprazole in preventing aspirin-induced gastric and duodenal ulcers

Conditions: Stomach Ulcer; Duodenal Ulcer

Summary: the purpose of this study is to determine whether lansoprazole, once daily (qd), compared to gefarnate, twice daily (bid), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.

in japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. while low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death. the purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.

Eligibility criteria:
inclusion criteria: * the patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started. * the patient was confirmed to have a history of gastric ulcer or duodenal ulcer. exclusion criteria: * endoscopically confirmed gastric and/or duodenal ulcers on day 1. * endoscopically confirmed active upper gastrointestinal hemorrhage on day 1. * current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs. * past or planned surgery affecting gastric acid secretion. * clinically significant hepatic or renal disorder.

Keywords: curling ulcer gastric ulcer aspirin acetylsalicylic acid drug therapy
a comparison of general versus peripheral nerve block for lower extremity amputation in diabetic patients with bleeding tendency: a retrospective study

Conditions: Daibetic Foot

Summary: retrospective data collection. the aim of this study is to compare general anesthesia and nerve block anesthesia with respect to the postoperative complications in patients undergoing diabetic leg amputation and having bleeding tendency.


Eligibility criteria:
inclusion criteria: 1.adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or pnb and having coagulopathy in which condition that neuraxial block is contraindicated exclusion criteria: 1. patients with prior surgical history within 1 month 2. combined operation (joint operation) 3. patients who required continuous intravenous administration of vasopressors and/or mechanical ventilation prior to surgery 4. combination of general anesthesia and pnb
anidulafungin during continuous venovenous hemofiltration (cvvhf)

Conditions: Acute Renal Failure; Infection

Summary: the purpose of this trial is to study the pharmacokinetics of anidulafungin during continuous venovenous hemofiltration. background: anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. members of this class of antifungal agents are known to inhibit the synthesis of glucan polymers in fungal cell walls. the spectrum of activity of anidulafungin includes candida (all species, including strains resistant to fluconazole), aspergillus, and pneumocystis. in intensive care patients continuous venovenous haemodiafiltration (cvvhf) is a well-established extracorporal renal replacement therapy with a high clearance rate. pharmacokinetic studies of antifungal agents in critically ill patients treated with cvvhf are rare. no data about anidulafungin in cvvhf are available although intensive care patients are perfect candidates for anidulafungin treatment due to their high risk profile for systemic fungal infections. study objective: the study is conducted to investigate the pharmacokinetics of anidulafungin during cvvhf in critically ill patients. study design: open, 1 arm study population: 10 critically ill adult patients administered to the icu with acute renal failure and suspected or proven fungal infection. treatment/dosage/route: on the first day 200 mg of anidulafungin will be administered intravenously over 3 hours (loading dose). the following days 100 mg of anidulafungin will be administered intravenously over 1.5 hours. main outcome variables: the following pharmacokinetic parameters will be determined: area under the curve (auc), half-live (t1/2), maximum plasma concentration (cmax) and elimination fraction. methods: high pressure liquid chromatography (hplc) will be used to determine anidulafungin concentrations.


Eligibility criteria:
inclusion criteria: * age 19 to 70 years * suspected or proven infection requiring parenteral antifungal therapy. * continuous venovenous hemofiltration because of an acute renal failure. exclusion criteria: * known history of hypersensitivity to echinocandins. * an expected survival of less than three days. * known alcohol dependency, epilepsy, pregnancy or liver failure. * neutropenic patients

Keywords: pharmacokinetics renal replacement therapy hemofiltration anidulafungin
sensitivity and specificity of cytokines in the diagnosis of lymphoma-associated hlh

Conditions: Hemophagocytic Lymphohistiocytoses; Lymphoma

Summary: lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. early identification and diagnosis of lymphoma-associated hlh has become the key to improve the prognosis of lymphoma-associated hlh. therefore, we conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated hlh.

lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. without early intervention, the median survival time is less than 2 months. early identification and diagnosis of lymphoma-associated hlh has become the key to improve the prognosis of lymphoma-associated hlh. therefore, it is urgent to find a method for the early diagnosis of lymphoma-associated hlh. we conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated hlh, and its correlation with disease severity, treatment response, and prognosis.

Eligibility criteria:
inclusion criteria: * age 40-75, gender is not limited. * patients with histopathologically confirmed lymphoma who meet hlh-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment. * patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment. * informed consent obtained. exclusion criteria: * patients with severe active infections (viral, bacterial, fungal, or parasitic). * patients with active autoimmune disease or a history of organ transplantation who are receiving immunosuppressive therapy. * patients with other type of malignant tumors within 5 years, except for cured solid tumors. * patients planned to receive immunotherapy. * pregnant and breastfeeding females. * history of human immunodeficiency virus (hiv) infection. * acute or chronic active hepatitis b or hepatitis c. * patients assessed as ineligible for the study by the investigator.

Keywords: hemophagocytic lymphohistiocytosis lymphoma cytokine diagnosis